On September 21, 2022 Merck KGaA, Darmstadt, Germany, a leading science and technology company, reported a collaboration agreement with licensing option with Nerviano Medical Sciences S.r.l. (NMS) for the next-generation highly selective and brain-penetrant PARP1 (poly (ADP-ribose) polymerase) inhibitor, NMS-293 (Press release, Merck KGaA, SEP 21, 2022, View Source [SID1234621312]). NMS-293 has strong potential in combination with a wide variety of DNA-damaging agents, including systemic or targeted chemotherapy (Antibody-Drug Conjugates) or with DNA damage response inhibitors, in numerous tumor types. NMS-293 is in early clinical development for the treatment of patients with BRCA-mutated tumors as a single agent and in combination with temozolomide in recurrent glioblastoma.
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"Building on the therapeutic impact that PARP inhibitors have had over the last several years, we believe this new PARP1 program, if successful, could fill a significant unmet need for patients unresponsive to existing PARP inhibitors with an improved hematological adverse event profile," said Victoria Zazulina, M.D., Head of Development Unit, Oncology, for the Healthcare business of Merck KGaA, Darmstadt, Germany. "The work of NMS to discover and advance this next generation PARP1 selective inhibitor coupled with our deep expertise in developing therapies which modify DNA damage response mechanisms, creates a strong foundation to further develop this investigational therapy for patients."
PARP is key in the repair of DNA damage, and PARP inhibitors have been shown to be highly efficacious in the treatment of patients with tumors deficient in homologous recombination repair, such as breast, ovarian, prostate and pancreatic cancers with BRCA-mutations.
Under the current agreement, Merck KGaA, Darmstadt, Germany will make early payments (up-front and option exercise fees) of up to $65 million to NMS. Furthermore, NMS will receive payments for the achievement of certain development, regulatory and commercial milestones and tiered royalties on net sales by Merck KGaA, Darmstadt, Germany. Upon exercise of the option, NMS will grant to Merck KGaA, Darmstadt, Germany the exclusive rights to research, develop, manufacture, and commercialize NMS-293.
During the option period, NMS and Merck KGaA, Darmstadt, Germany will collaborate on the clinical development of NMS-293, with NMS designing, sponsoring, conducting, and funding global clinical trials.
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About NMS-293
NMS-293 is an orally available small molecule inhibitor of PARP1 and is currently in early clinical development for the treatment of patients with BRCA mutated tumors as single agent and with recurrent Glioblastoma (GBM), a brain tumor with very high medical need, in combination with temozolomide (TMZ).